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Improved Pre-Operative Staging of Pancreatic Cancer Using Superparamagnetic Iron Oxide Magnetic Resonance Imaging (SPIO MRI)


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Cancer

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Trial Information

Improved Pre-Operative Staging of Pancreatic Cancer Using Superparamagnetic Iron Oxide Magnetic Resonance Imaging (SPIO MRI)


- On the first day, study participants will undergo 2 MRI examinations. A scan will be
done prior to administration of the contrast agent (Feraheme) and then a second scan
immediately after administration. On the second day, study participants will be asked
to return for a third MRI.

- All MRI scans will be done at Massachusetts General Hospital.


Inclusion Criteria:



- Locally resectable pancreatic mass present on one or more pre-operative imaging
modalities

- Must demonstrate no evidence of distant metastases as assessed by
chest/abdomen/pelvis CT scan

- Deemed eligible for resection with curative intent by a treating surgeon who is
listed as an investigator on this study

- 18 years of age or older

- No uncontrolled serious medical or psychiatric illness

- Women of childbearing potential must not be pregnant or lactating

Exclusion Criteria:

- Known allergy to iron or dextran

- Pregnant or lactating

- Counter-indication to MRI, such as the presence of metallic prostheses or implanted
metal device

- Sickle cell disease or hemoglobinopathy

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

To determine the sensitivity and specificity of high resolution magnetic resonance imaging with lymphotrophic superparamagnetic nanoparticles to identify small and otherwise undetectable lymph node metastases.

Outcome Time Frame:

3 years

Safety Issue:

Yes

Principal Investigator

Ralph Weissleder, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachussetts General Hospital

Authority:

United States: Institutional Review Board

Study ID:

08-085

NCT ID:

NCT00920023

Start Date:

July 2008

Completion Date:

October 2013

Related Keywords:

  • Pancreatic Cancer
  • SPIO MRI
  • Feridex
  • Pancreatic Neoplasms

Name

Location

Massachusetts General HospitalBoston, Massachusetts  02114-2617